Idiopathic Toe WalkingNCT06010485
The Effect of Serial Casting and Physical Therapy in Children With Idiopathic Toe Walking
A study testing Serial Casting and Exercise in people with Idiopathic Toe Walking, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Children who continue to walk on their tiptoes after developing a heel-toe gait normally are diagnosed with idiopathic toe walking (ITW). The study's aim was to investigate the effects of serial casting and physical therapy on joint range of motion (ROM), toe walking severity, functional health and health-related… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Idiopathic Toe Walking
- What is being tested?
- Serial Casting and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 3-10 years
- Patients with idiopathic toe walking diagnosis
- To be evaluated by a pediatric neurologist, not to have abnormal findings in cranial and all spinal magnetic resonance imaging and electrophysiological examinations performed when deemed necessary, and creatinine kinase values are within normal limits ((Absence of any neurological, orthopedic or psychiatric pathology to explain the toe walking pattern (cerebral palsy, neuropathy, myopathy, autism, developmental disorders, etc.)
Who cannot join
- Have previously conservative or surgical treatment
- Presence of plantar flexion contracture
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Trainig and Research Hospital
Istanbul, 34752
About this study
Official title: The Effect of Serial Casting and Physical Therapy on Ankle Range of Motion, Toe Walking Severity, Walking Balance, Functional Health Related Quality of Life in Children With Idiopathic Toe Walking
Children who continue to walk on their tiptoes after developing a heel-toe gait normally are diagnosed with idiopathic toe walking (ITW). The study's aim was to investigate the effects of serial casting and physical therapy on joint range of motion (ROM), toe walking severity, functional health and health-related quality of life, walking balance, and satisfaction from treatment in ITW, in comparison with the control group.
Read the detailed description
Children with ITW aged 3-10 years are randomized into three groups: the serial casting group (n=10), the physical therapy group (n=10), and the wait-list control group (n=10). Patients with ankle contracture and previous interventions are excluded. The serial casting group is planned to receive intermittent serial casting once every three days for three weeks. The physical therapy group is planned to undergo three sessions per week for three weeks, consisting of stretching exercises, strengthening exercises, balance training, proprioception exercises, and walking on heels. The patients were assessed by blinded investigators at before treatment (BT), post-treatment (PT: 3th week), 1st month (1MPT), 3rd months (3MPT), and 6th months post-treatment (6MPT). To ensure ethical considerations, only control group was followed-up until the 1MPT.
- Conditions
- Idiopathic Toe Walking
- Being tested
- Serial Casting, Exercise
- Keywords
- Idiopathic Toe Walking, Serial Casting, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial CastingOther
A short leg cast is applied to the serial casting group by an orthopedic specialist once every three days for three weeks.
ExerciseOther
Stretching exercises, strengthening exercises, balance exercises, proprioception exercises, and heel walking exercises are applied to the physical therapy group for 3 weeks with a physiotherapist for 3 sessions a week.
| Study group | Role | What they receive |
|---|---|---|
| Serial Casting | Active comparator | The serial casting group received intermittent serial casting once every three days for three weeks. Receives: Other: Serial Casting |
| Exercise | Active comparator | The physical therapy group underwent three sessions per week for three weeks, consisting of stretching exercises, strengthening exercises, balance training, proprioception exercises, and walking on heels. Receives: Other: Exercise |
| Control Group | No intervention | This group consists of the patients on the waitlist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion (ROM)
Ankle dorsiflexion ROM with extended knee
Measured: Day 0
Range of Motion (ROM)
Ankle dorsiflexion ROM with extended knee
Measured: 3rd week
Range of Motion (ROM)
Ankle dorsiflexion ROM with extended knee
Measured: 7th week
Range of Motion (ROM)
Ankle dorsiflexion ROM with extended knee
Measured: 15th week
Range of Motion (ROM)
Ankle dorsiflexion ROM with extended knee
Measured: 27th week
Range of Motion (ROM)
Ankle dorsiflexion ROM with flexed knee
Measured: Day 0
Range of Motion (ROM)
Ankle dorsiflexion ROM with flexed knee
Measured: 3rd week
Range of Motion (ROM)
Ankle dorsiflexion ROM with flexed knee
Measured: 7th week
Range of Motion (ROM)
Ankle dorsiflexion ROM with flexed knee
Measured: 15th week
Range of Motion (ROM)
Ankle dorsiflexion ROM with flexed knee
Measured: 27th week
Toe Walking Severity Scale
The family is asked how long the child tiptoe walks during the day. The evaluation is as follows.
Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait <10%) Stage 6: Normal heel strike
Measured: Day 0
Toe Walking Severity Scale
The family is asked how long the child tiptoe walks during the day. The evaluation is as follows.
Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait <10%) Stage 6: Normal heel strike
Measured: 3rd week
Toe Walking Severity Scale
The family is asked how long the child tiptoe walks during the day. The evaluation is as follows.
Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait <10%) Stage 6: Normal heel strike
Measured: 7th week
Toe Walking Severity Scale
The family is asked how long the child tiptoe walks during the day. The evaluation is as follows.
Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait <10%) Stage 6: Normal heel strike
Measured: 15th week
Toe Walking Severity Scale
The family is asked how long the child tiptoe walks during the day. The evaluation is as follows.
Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait <10%) Stage 6: Normal heel strike
Measured: 27th week
Secondary outcomes (14)
Pediatric Outcomes Data Collection Instrument (PODCI)
PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.
Measured: Day 0
Pediatric Outcomes Data Collection Instrument (PODCI)
PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.
Measured: 3rd week
Pediatric Outcomes Data Collection Instrument (PODCI)
PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.
Measured: 7th week
Pediatric Outcomes Data Collection Instrument (PODCI)
PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.
Measured: 15th week
Pediatric Outcomes Data Collection Instrument (PODCI)
PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.
Measured: 27th week
Tandem Walk Test
The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.
Measured: Day 0
Tandem Walk Test
The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.
Measured: 3rd week
Tandem Walk Test
The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.
Measured: 7th week
Tandem Walk Test
The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.
Measured: 15th week
Tandem Walk Test
The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.
Measured: 27th week
Visual Analog Scale
All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)
Measured: 3rd week
Visual Analog Scale
All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)
Measured: 7th week
Visual Analog Scale
All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)
Measured: 15th week
Visual Analog Scale
All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)
Measured: 27th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion15 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Toe WalkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single blinded, controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esra Giray, Principal investigator, Fatih Sultan Mehmet training and Research Hospital, Istanbul-Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010485
- Sponsor's protocol ID
- illeezozge
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pomarino D, Ramirez Llamas J, Martin S, Pomarino A. Literature Review of Idiopathic Toe Walking: Etiology, Prevalence, Classification, and Treatment. Foot Ankle Spec. 2017 Aug;10(4):337-342. doi: 10.1177/1938640016687370. Epub 2017 Jan 16.
PubMed 28092971Engelbert R, Gorter JW, Uiterwaal C, van de Putte E, Helders P. Idiopathic toe-walking in children, adolescents and young adults: a matter of local or generalised stiffness? BMC Musculoskelet Disord. 2011 Mar 21;12:61. doi: 10.1186/1471-2474-12-61.
PubMed 21418634Herrin K, Geil M. A comparison of orthoses in the treatment of idiopathic toe walking: A randomized controlled trial. Prosthet Orthot Int. 2016 Apr;40(2):262-9. doi: 10.1177/0309364614564023. Epub 2015 Jan 27.
PubMed 25628380Pomarino D, Ramirez Llamas J, Pomarino A. Idiopathic Toe Walking: Family Predisposition and Gender Distribution. Foot Ankle Spec. 2016 Oct;9(5):417-22. doi: 10.1177/1938640016656780. Epub 2016 Jul 1.
PubMed 27370652Satila H, Beilmann A, Olsen P, Helander H, Eskelinen M, Huhtala H. Does Botulinum Toxin A Treatment Enhance the Walking Pattern in Idiopathic Toe-Walking? Neuropediatrics. 2016 Jun;47(3):162-8. doi: 10.1055/s-0036-1582138. Epub 2016 Apr 18.
PubMed 27089542Engstrom P, Bartonek A, Tedroff K, Orefelt C, Haglund-Akerlind Y, Gutierrez-Farewik EM. Botulinum toxin A does not improve the results of cast treatment for idiopathic toe-walking: a randomized controlled trial. J Bone Joint Surg Am. 2013 Mar 6;95(5):400-7. doi: 10.2106/JBJS.L.00889.
PubMed 23467862Williams CM, Tinley P, Curtin M. The Toe Walking Tool: a novel method for assessing idiopathic toe walking children. Gait Posture. 2010 Oct;32(4):508-11. doi: 10.1016/j.gaitpost.2010.07.011. Epub 2010 Aug 7.
PubMed 20692159Giray E, Akpinar P, Illeez OG, Kahraman HC, Kocibar M, Kutsal A, Hacifazlioglu NE, Uyur E, Unlu Ozkan F, Aktas I, Yilmaz B, Karadag-Saygi E. A comparative randomized-controlled trial of serial casting and exercises on ankle range of motion, toe walking severity, walking balance, and functional health-related quality of life in children with idiopathic toe walking. J Pediatr Orthop B. 2025 Sep 1;34(5):465-476. doi: 10.1097/BPB.0000000000001250. Epub 2025 Jul 29.
PubMed 40167594
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Serial Casting and Physical Therapy on Ankle Range of Motion, Toe Walking Severity, Walking Balance, Functional Health Related Quality of Life in Children With Idiopathic Toe Walking
- ClinicalTrials.gov ID
- NCT06010485
- Acronym / sponsor ID
- illeezozge
- Conditions
- Idiopathic Toe Walking
- Keywords
- Idiopathic Toe Walking, Serial Casting, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children who continue to walk on their tiptoes after developing a heel-toe gait normally are diagnosed with idiopathic toe walking (ITW). The study's aim was to investigate the effects of serial casting and physical therapy on joint range of motion (ROM), toe walking severity, functional health and health-related quality of life, walking balance, and satisfaction from treatment in ITW, in comparison with the control group.
Detailed description
Children with ITW aged 3-10 years are randomized into three groups: the serial casting group (n=10), the physical therapy group (n=10), and the wait-list control group (n=10). Patients with ankle contracture and previous interventions are excluded. The serial casting group is planned to receive intermittent serial casting once every three days for three weeks. The physical therapy group is planned to undergo three sessions per week for three weeks, consisting of stretching exercises, strengthening exercises, balance training, proprioception exercises, and walking on heels. The patients were assessed by blinded investigators at before treatment (BT), post-treatment (PT: 3th week), 1st month (1MPT), 3rd months (3MPT), and 6th months post-treatment (6MPT). To ensure ethical considerations, only control group was followed-up until the 1MPT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, single blinded, controlled study
| Arm | Type | Receives |
|---|---|---|
| Serial Casting | Active comparator | Other: Serial CastingThe serial casting group received intermittent serial casting once every three days for three weeks. |
| Exercise | Active comparator | Other: ExerciseThe physical therapy group underwent three sessions per week for three weeks, consisting of stretching exercises, strengthening exercises, balance training, proprioception exercises, and walking on heels. |
| Control Group | No intervention | –This group consists of the patients on the waitlist. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 3-10 years
- Patients with idiopathic toe walking diagnosis
- To be evaluated by a pediatric neurologist, not to have abnormal findings in cranial and all spinal magnetic resonance imaging and electrophysiological examinations performed when deemed necessary, and creatinine kinase values are within normal limits ((Absence of any neurological, orthopedic or psychiatric pathology to explain the toe walking pattern (cerebral palsy, neuropathy, myopathy, autism, developmental disorders, etc.)
Key exclusion criteria (2 listed)
- Have previously conservative or surgical treatment
- Presence of plantar flexion contracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serial CastingA short leg cast is applied to the serial casting group by an orthopedic specialist once every three days for three weeks. | Other | Serial Casting |
| ExerciseStretching exercises, strengthening exercises, balance exercises, proprioception exercises, and heel walking exercises are applied to the physical therapy group for 3 weeks with a physiotherapist for 3 sessions a week. | Other | Exercise |
Primary outcome
Range of Motion (ROM)
Time frame: Day 0
Ankle dorsiflexion ROM with extended knee
Range of Motion (ROM)
Time frame: 3rd week
Ankle dorsiflexion ROM with extended knee
Range of Motion (ROM)
Time frame: 7th week
Ankle dorsiflexion ROM with extended knee
Range of Motion (ROM)
Time frame: 15th week
Ankle dorsiflexion ROM with extended knee
Range of Motion (ROM)
Time frame: 27th week
Ankle dorsiflexion ROM with extended knee
Range of Motion (ROM)
Time frame: Day 0
Ankle dorsiflexion ROM with flexed knee
Range of Motion (ROM)
Time frame: 3rd week
Ankle dorsiflexion ROM with flexed knee
Range of Motion (ROM)
Time frame: 7th week
Ankle dorsiflexion ROM with flexed knee
Range of Motion (ROM)
Time frame: 15th week
Ankle dorsiflexion ROM with flexed knee
Range of Motion (ROM)
Time frame: 27th week
Ankle dorsiflexion ROM with flexed knee
Toe Walking Severity Scale
Time frame: Day 0
The family is asked how long the child tiptoe walks during the day. The evaluation is as follows. Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait <10%) Stage 6: Normal heel strike
Toe Walking Severity Scale
Time frame: 3rd week
The family is asked how long the child tiptoe walks during the day. The evaluation is as follows. Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait <10%) Stage 6: Normal heel strike
Toe Walking Severity Scale
Time frame: 7th week
The family is asked how long the child tiptoe walks during the day. The evaluation is as follows. Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait <10%) Stage 6: Normal heel strike
Toe Walking Severity Scale
Time frame: 15th week
The family is asked how long the child tiptoe walks during the day. The evaluation is as follows. Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait <10%) Stage 6: Normal heel strike
Toe Walking Severity Scale
Time frame: 27th week
The family is asked how long the child tiptoe walks during the day. The evaluation is as follows. Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait <10%) Stage 6: Normal heel strike
14 secondary outcomes
Pediatric Outcomes Data Collection Instrument (PODCI)
Time frame: Day 0
Pediatric Outcomes Data Collection Instrument (PODCI)
Time frame: 3rd week
Pediatric Outcomes Data Collection Instrument (PODCI)
Time frame: 7th week
Pediatric Outcomes Data Collection Instrument (PODCI)
Time frame: 15th week
Pediatric Outcomes Data Collection Instrument (PODCI)
Time frame: 27th week
Tandem Walk Test
Time frame: Day 0
Tandem Walk Test
Time frame: 3rd week
Tandem Walk Test
Time frame: 7th week
Tandem Walk Test
Time frame: 15th week
Tandem Walk Test
Time frame: 27th week
Visual Analog Scale
Time frame: 3rd week
Visual Analog Scale
Time frame: 7th week
Visual Analog Scale
Time frame: 15th week
Visual Analog Scale
Time frame: 27th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Background: PubMed 28092971Pomarino D, Ramirez Llamas J, Martin S, Pomarino A. Literature Review of Idiopathic Toe Walking: Etiology, Prevalence, Classification, and Treatment. Foot Ankle Spec. 2017 Aug;10(4):337-342. doi: 10.1177/1938640016687370. Epub 2017 Jan 16.
- Background: PubMed 21418634Engelbert R, Gorter JW, Uiterwaal C, van de Putte E, Helders P. Idiopathic toe-walking in children, adolescents and young adults: a matter of local or generalised stiffness? BMC Musculoskelet Disord. 2011 Mar 21;12:61. doi: 10.1186/1471-2474-12-61.
- Background: PubMed 25628380Herrin K, Geil M. A comparison of orthoses in the treatment of idiopathic toe walking: A randomized controlled trial. Prosthet Orthot Int. 2016 Apr;40(2):262-9. doi: 10.1177/0309364614564023. Epub 2015 Jan 27.
- Background: PubMed 27370652Pomarino D, Ramirez Llamas J, Pomarino A. Idiopathic Toe Walking: Family Predisposition and Gender Distribution. Foot Ankle Spec. 2016 Oct;9(5):417-22. doi: 10.1177/1938640016656780. Epub 2016 Jul 1.
- Background: PubMed 27089542Satila H, Beilmann A, Olsen P, Helander H, Eskelinen M, Huhtala H. Does Botulinum Toxin A Treatment Enhance the Walking Pattern in Idiopathic Toe-Walking? Neuropediatrics. 2016 Jun;47(3):162-8. doi: 10.1055/s-0036-1582138. Epub 2016 Apr 18.
- Background: PubMed 23467862Engstrom P, Bartonek A, Tedroff K, Orefelt C, Haglund-Akerlind Y, Gutierrez-Farewik EM. Botulinum toxin A does not improve the results of cast treatment for idiopathic toe-walking: a randomized controlled trial. J Bone Joint Surg Am. 2013 Mar 6;95(5):400-7. doi: 10.2106/JBJS.L.00889.
- Background: PubMed 20692159Williams CM, Tinley P, Curtin M. The Toe Walking Tool: a novel method for assessing idiopathic toe walking children. Gait Posture. 2010 Oct;32(4):508-11. doi: 10.1016/j.gaitpost.2010.07.011. Epub 2010 Aug 7.
- Derived from this study: PubMed 40167594Giray E, Akpinar P, Illeez OG, Kahraman HC, Kocibar M, Kutsal A, Hacifazlioglu NE, Uyur E, Unlu Ozkan F, Aktas I, Yilmaz B, Karadag-Saygi E. A comparative randomized-controlled trial of serial casting and exercises on ankle range of motion, toe walking severity, walking balance, and functional health-related quality of life in children with idiopathic toe walking. J Pediatr Orthop B. 2025 Sep 1;34(5):465-476. doi: 10.1097/BPB.0000000000001250. Epub 2025 Jul 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Giray principal investigator
Fatih Sultan Mehmet training and Research Hospital, Istanbul-Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serial Casting and Exercise in people with Idiopathic Toe Walking, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esra Giray (+905558134394, girayesra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (ROM) (time frame: Day 0). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06010485, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.